Treatment & perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors in adults eg, deficiency caused by treatment or overdose w/ vit K antagonists, when rapid correction of deficiency is required. Treatment & perioperative prophylaxis of haemorrhages in congenital deficiency of vit K-dependent coagulation factors in adults when purified specific coagulation factor conc is not available.
IV Not to administer >2 mL/min (60 IU/min). Individualized dose. Max single dose: 50 IU/kg. Bleeding & perioperative prophylaxis of bleeding during vit K antagonist treatmentINR >6 50 IU/kg, 4-6 35 IU/kg, 2-3.9 25 IU/kg.
Discontinue inj/infusion immediately if allergic or anaphylactic-type reactions occur. Avoid use in patients w/ history of heparin-induced allergic reactions. May exacerbate underlying hypercoagulable state in patients receiving vit K antagonist. Risk of thrombosis & disseminated intravascular coagulation (DIC) (higher risk in treatment of isolated FVII deficiency); arterial & venous thromboembolic events including MI, CVA (eg, stroke), pulmonary embolism. Patients w/ history of CHD; who are pre- or post-op; at risk of thromboembolic events or DIC. Adults on controlled Na diet. Observe closely for signs & symptoms of intravascular coagulation or thrombosis. Consider regular/repeated administration of appropriate vaccinations (hepatitis A & B). Liver disease. Pregnancy & lactation. Neonates & childn.
B02BD01 - coagulation factor IX, II, VII and X in combination ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
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